In vitro diagnostics, the ability to measure and monitor various biological related markers from patient samples, has continued to gain prominence as a valuable input for physician decision making. The majority of clinical diagnostic tests are performed in a centralized lab located in a hospital or through an outside testing service. This procedure often delays results and adds significant costs to the healthcare system. In particular, for certain critical bio-markers there is a pressing need for quantification in the ultrasensitive regime, analyte concentrations in the femtomolar range and below, combined with short assay times so that medical intervention can take place more efficiently.
Most large and expensive clinical laboratory machinery can fulfill the quantitation aspect of testing but cannot deliver attractive turnaround time, a portable format, and attractive economics. A small but capable system that could be operated by a skilled or unskilled user could drastically improve patient outcomes.
Mentioned in the art are various point of care test systems incorporating a consumable that contains sensors of types including but not limited to: electrochemical, lateral flow, fluorescent, chemiluminescent, magnetic etc. However, there remains a latent need for a test system with a consumable cartridge that provides a platform for more robust and flexible testing. This type of cartridge format would provide fast assay times, performance that meets or exceeds laboratory instrumentation, ability to conduct multiple assays, ability to conduct multiple protocols, all constructed from components made of inexpensive materials.